Post-Authorization Safety Studies (PASS)
Pharmacovigilance
Post-Authorization Safety Studies (PASS) are crucial for ongoing assessment of the safety profile of medicinal products after they have entered the market. PASS helps identify, characterize, and quantify risks in real-world settings, supporting regulatory compliance and informed benefit-risk management.
PVpharm supports Marketing Authorization Holders in the planning and execution of Post-Authorization Safety Studies (PASS), ensuring scientific robustness and full compliance with regulatory requirements and Good Pharmacovigilance Practices (GVP).
Our services include:
- Protocol review: Regulatory and methodological support in the review of study protocols to ensure compliance with EMA guidance and study objectives.
- SMP creation: to define responsibilities during the PASS
- Submission and approval: Support during the coordination with regulatory authorities including submission and approval processes
- Study management and monitoring: to ensure timely and high-quality data collection
- Data management: Data analysis and medical evaluation of safety findings
- Study reports: Preparation of study reports compliant with EMA and FDA expectations
